Charles River Laboratories International, Inc. has advanced the innovation one step further and combined it with their recombinant cascade reagent (rCR) to launch the Endosafe® Trillium? rCR cartridge offering. Expanding its robust bacterial endotoxin testing (BET) portfolio with a new animal-free testing solution, this offering, which builds on Charles River?s existing Trillium rCR vial product, enhances testing efficiency and accelerates manufacturing timelines while simultaneously contributing to Charles River's 4Rs imperatives (Replacement, Reduction, Refinement, and Responsibility) and further progressing the company's clients goals on sustainability and animal welfare.

Designed to deliver rapid, quantitative results, the rCR cartridges are pre-loaded with all the reagents required to perform an endotoxin test, eliminating need for preparation of multiple reagents, and reducing the opportunity for technician error. Additionally, the product is fully aligned and integrated with Charles River?s existing suite of Endosafe cartridge instrumentation and software, allowing for current limulus amebocyte lysate (LAL) cartridge clients to transition seamlessly. Historically, endotoxin testing has relied on the Atlantic horseshoe crab, whose blood contains LAL, an aqueous extract of blood cells.

LAL is the critical component of the testing of implantable medical devices and injectable pharmaceutical products to ensure the absence of endotoxins that can cause pyrogenic responses and symptoms of septic shock. The Trillium rCR formulation within the cartridge technology detects and quantifies natural environmental endotoxins by simulating the LAL enzymatic cascade through an optimized formulation and composition of three recombinant proteins (recombinant Factor C, recombinant Factor B, and recombinant proclotting enzyme) and a specific concentration of key components. The company's extensive data package supporting the company's proprietary matrix demonstrates assay superiority in accuracy, comparability, and robustness.

Charles River continues to apply the highest scientific standards when offering new and innovative products in its BET portfolio. The Trillium cartridge was developed following a data-driven decision-making process to create a product that ultimately will provide the highest quality results among recombinant technologies and ensure patient safety. Samples representing a wide group of product types from global geographies were tested through a beta study of existing cartridge clients.

The results for these samples showed equivalency within that data set, supporting the claim of equivalency to LAL.